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Continuous Glucose Monitor in Children With Poorly Controlled Diabetes 30

Completed
Clinical Trial NCT02530450 was an observational study for Type 1 Diabetes Mellitus that is now completed. The study started on May 1, 2011, with plans to enroll 30 participants. Led by The University of Texas Health Science Center at San Antonio, the expected completion date was March 1, 2013. The latest data from ClinicalTrials.gov was last updated on October 6, 2017.
Brief Summary
The purpose of this study is to determine if the use of continuous glucose monitoring in a practical outpatient clinic setting in children with poorly controlled diabetes will lead to improved blood sugar control.
Detailed Description
The trial was designed as a six month, randomized, prospective, interventional pilot study of children with uncontrolled (HgbA1c > 8.5%) diabetes who were between the ages of 7-17 years of age. The purpose of the study was to determine the effect in glycemic control as measured by HgbA1c with use of iPro™ CGM at regularly scheduled clinic appointments. Recruitment for this study was limited to patients at the Univer...Show More
Official Title

iPro Continuous Glucose Monitor in Children With Poorly Controlled Diabetes: A 6-Month, Randomized, Interventional Pilot Study

Conditions
Type 1 Diabetes Mellitus
Publications
Scientific articles and research papers published about this clinical trial:
Other Study IDs
  • HSC20110049H
NCT ID Number
NCT02530450
Start Date (Actual)
2011-05
Last Update Posted
2017-10-06
Completion Date (Estimated)
2013-03
Enrollment (Estimated)
30
Study Type
Observational
Status
Completed
Keywords
children
poor adherence
continuous glucose monitoring
Arms / Interventions
Participant Group/ArmIntervention/Treatment
Group 1
Initially blinded to continuous glucose monitoring (CGM) data after 1st use Not blinded to continuous glucose monitoring data after 2nd and 3rd use
continuous glucose monitoring (CGM)
All subjects in Groups 1 and 2 wore the CGM device at time points 0, 3 months, and 6 months. Group 1 did not review CGM data at time 0, but did review CGM data at time point 3 months and 6 months. Group 2 reviewed CGM data at all time points.
Group 2
Never blinded to continuous glucose monitoring (CGM) data
continuous glucose monitoring (CGM)
All subjects in Groups 1 and 2 wore the CGM device at time points 0, 3 months, and 6 months. Group 1 did not review CGM data at time 0, but did review CGM data at time point 3 months and 6 months. Group 2 reviewed CGM data at all time points.
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
The Primary Outcome Measure Was Change in HgbA1c
0 months, 3 months and 6 months
Secondary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
% Time Spent in Hypoglycemia, Hyperglycemia, and Euglycemia
3 months and 6 months
Eligibility Criteria

Eligible Ages
Child
Minimum Age
7 Years
Eligible Sexes
All
  1. Clinical diagnosis of diabetes for at least 6 months, type 1 or type 2 diabetes.
  2. Treated at UT Health Science Center pediatric diabetes clinic for at least the previous 3 months.
  3. HgbA1c >8.5% (equivalent to average BG of >205 mg/dL for past three months).
  4. Supportive family with willingness to self monitoring blood glucose values at least 4 times per day during study.
  5. Supportive family with willingness to participate in continuous glucose monitoring (CGM) for at least 48 hours including self monitoring blood glucose values at least 4 times per day, documenting meals, carbohydrates eaten, insulin dose given, exercise, and hypoglycemic symptoms.
  6. Attend proposed clinic, nutritional, and CGM follow up visits.
  7. Pump or multiple daily injection (MDI) insulin therapy (3-4 injections minimum daily). If on pump, on pump for at least the past 3 months. Current insulin regimen involves basal/ bolus therapy with no plans to switch the modality of insulin administration during the study (e.g., injection user switching to a pump, pump user switching to injections).
  8. Hypoglycemic unawareness.
  9. English or Spanish primary language.

  1. Medications known to affect glycemic control (oral steroids, growth hormone, psychotropics).
  2. Documented concomitant chronic disease known to affect glycemic control.
  3. 3 or more incidents in the last 12 months of severe hypoglycemia with documented blood glucose below 50mg/dL (if possible), resulting in unconsciousness, hospitalization or third party assistance, where recovery follows treatment with glucose or glucagon or similar.
  4. 3 or more incidents in the last 12 months of diabetic ketoacidosis (DKA).
  5. Reported alcohol or drug abuse.
  6. Documented cutaneous allergy to latex products.
  7. Documented eating disorders or morbid obesity as assessed by the investigator.
  8. Any other medical, social or psychological condition that, in the investigator's opinion, makes the patient unable to comply with the study protocol and all study procedures.
  9. Home use of CGM in the past 6 months.
The University of Texas Health Science Center at San Antonio logoThe University of Texas Health Science Center at San Antonio
Medtronic Diabetes logoMedtronic Diabetes
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